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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Occlusive
510(k) Number K941789
Device Name PRO-TECT TRAUMA PAK
Applicant
Pro-Tect Medical Products, Inc.
9940 Hamilton Rd.
Eden Prairie,  MN  55344
Applicant Contact LEO J UTECHT
Correspondent
Pro-Tect Medical Products, Inc.
9940 Hamilton Rd.
Eden Prairie,  MN  55344
Correspondent Contact LEO J UTECHT
Classification Product Code
MGP  
Date Received04/11/1994
Decision Date 01/12/1995
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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